FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)
Leading manufacturers include Ambu, Inc., Puritan Bennett Corp. and Medical Marketing Concepts.
209
Total
209
Cleared
124d
Avg days
1976
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
155d
recently vs 123d historically
FDA 510(k) Cleared Ventilator, Emergency, Manual (resuscitator) Devices (Product Code BTM)
209 devices
Cleared
Nov 24, 2025
The BAG manual resuscitator and accessories
Laerdal Medical AS
Anesthesiology
180d
Cleared
Apr 25, 2025
butterflyBVM
Compact Medical, Inc.
Anesthesiology
130d
Cleared
Mar 18, 2023
EOlife®
Archeon
Anesthesiology
267d
Cleared
Aug 18, 2022
Sotair Device
Safe Bvm Corporation
Anesthesiology
339d
Cleared
Aug 26, 2021
Disposable Manual Resuscitator
Xiamen Compower Medical Tech. Co., Ltd.
Anesthesiology
205d
Cleared
Dec 07, 2018
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
Flexicare Medical Limited.
Anesthesiology
175d
Cleared
May 11, 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Foremount Enterprise Co., Ltd.
Anesthesiology
431d
Cleared
Aug 29, 2016
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
Ambu A/S
Anesthesiology
329d
Cleared
Jan 15, 2015
NEONATALIE RESUSCITATOR
Laerdal Medical A/S
Anesthesiology
549d
Cleared
Jan 13, 2012
BABI PLUS NEONATAL RESUSCITATION BAG
A Plus Medical
Anesthesiology
87d
Cleared
Jan 28, 2011
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
Ambu A/S
Anesthesiology
121d
Cleared
Jan 31, 2008
RESUSCITATION TIMER, MODEL L770-CPR
Allied Healthcare Products, Inc.
Anesthesiology
83d
Cleared
Apr 20, 2007
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
Ohmeda Medical
Anesthesiology
85d
Cleared
Oct 18, 2006
RESUSCITATION TIMER, MODEL L770-CPR
Allied Healthcare Products, Inc.
Anesthesiology
89d
Cleared
Dec 23, 2005
AMBU MARK IV RESUSCITATOR
Ambu A/S
Anesthesiology
44d
Cleared
Dec 20, 2005
AMBU MARK IV BABY RESUSCITATOR
Ambu A/S
Anesthesiology
41d
Cleared
Aug 29, 2005
PVC AND SILICONE MANUAL RESUSCITATORS
David Medical Products Co.,Ltd
Anesthesiology
115d
Cleared
Mar 11, 2005
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
Enter Medical Corporation
Anesthesiology
172d
Cleared
Nov 15, 2004
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
Ambu, Inc.
Anesthesiology
47d
Cleared
Nov 12, 2004
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
Ambu, Inc.
Anesthesiology
29d
Cleared
Feb 11, 2003
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
Portex, Inc.
Anesthesiology
90d
Cleared
Feb 07, 2003
NELLCOR INDGO MANUAL RESUSCITATOR
Nellcor Puritan Bennett, Inc.
Anesthesiology
112d
Cleared
Oct 01, 2002
PMX DISPOSABLE BAG MASK RESUSCITATOR
Allied Healthcare Products, Inc.
Anesthesiology
295d
Cleared
Feb 27, 2002
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
Portex, Inc.
Anesthesiology
75d
About Product Code BTM - Regulatory Context
510(k) Submission Activity
209 total 510(k) submissions under product code BTM since 1976, with 209 receiving FDA clearance (average review time: 124 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - BTM Product Code
Recent submissions under BTM have taken an average of 155 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.
BTM devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →